Nemolizumab Pregnancy and Breastfeeding Warnings

Brand names: Nemluvio

Medically reviewed by Drugs.com. Last updated on Oct 7, 2024.

Nemolizumab Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Available data are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse fetal or maternal outcomes.

Comments:
-Human IgG antibody transport across the placenta increases during the third trimester, therefore, this drug may be transferred from the mother to the fetus.
-This drug may interfere with immune response to infections. Consider risks and benefits prior to administering live vaccines to infants exposed to this drug in utero. The levels of this drug in infant serum at birth are unknown, but a vaccination delay of a minimum of 3 months after birth is recommended based on the half-life of this product.

Animal studies showed an increase in early postnatal death when a subcutaneous dose 36 times the maximum recommended human dose (MRHD) was administered every 2 weeks to pregnant cynomolgus monkeys during organogenesis to parturition. No fetal or maternal toxicities were found at doses lower than 36 times the MRHD. The clinical significance of this finding is unknown. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Nemolizumab Breastfeeding Warnings

Benefit should outweigh risk.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Endogenous maternal IgG and monoclonal antibodies are transferred in human milk, however the effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant are unknown.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer